Effects of low-level red light therapy on myopic minors' eye health

Fundus Effects of Repeated Low-Level Red-Light Therapy in Chinese Myopic Minors: A Randomized Controlled Clinical Trial

This study is testing if low-level red light therapy can help improve eye health in kids aged 7 to 17 who are nearsighted, compared to those using regular glasses.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 7 Years to 17 Years
• Sex: All
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Academic / other)
• Locations: 1 site (Guangzhou)
• Trial ID: NCT06034912 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the short-term effects of repeated low-intensity red light therapy on the fundus of the eyes in minors aged 7 to 17 with myopia. It employs a randomized controlled design with participants divided into an experimental group receiving the therapy and a control group using standard corrective glasses. Various assessments, including optical coherence tomography and microperimetry, will be used to evaluate retinal functionality and potential damage. The study aims to provide insights into the safety and efficacy of this novel treatment approach for myopia management.

Who should consider this trial

Good fit: Ideal candidates are minors aged 7 to 17 with specific refractive errors and good visual acuity.

Not a fit: Patients with significant eye diseases or systemic conditions that affect vision will not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a new non-invasive treatment option to slow the progression of myopia in children.

How similar studies have performed: While the approach of using low-level red light therapy is relatively novel, similar studies have shown promising results in other contexts.

Eligibility criteria

Inclusion Criteria:

1. 7\~17 years old；
2. Spherical equivalent refraction (SER) -1.00 to -5.00D；
3. Astigmatism≤ 2.50D；
4. Anisometropia (difference between the two equivalent spherical lenses) ≤ 1.50D；
5. Best corrected visual acuity (BCVA) in either eye ≥ 20/20；
6. Currently willing to use low-intensity red light treatment；
7. Be able to understand the purpose of the trial, voluntarily participate and have the subject and his legal guardian sign an informed consent form.

Exclusion Criteria:

1. strabismus (apparent strabismus) or amblyopia；
2. Correction of abnormal vision in either eye；
3. Any eye disease that may be related to myopia or affect refractive development, such as history of photosensitivity, macular disease, moderate to severe dry eye, corneal disease, cataract, vitreoretinal disease, infectious conjunctivitis, uveitis, optic nerve damage, congenital optic nerve development abnormalities or other eye diseases；
4. Systemic diseases, such as hypertension, lupus erythematosus, albinism, diabetes, etc；
5. previous history of convulsions, tics, central nervous system underdevelopment, psoriasis, epilepsy and psychiatric and psychological diseases；
6. used within 3 months or planned to use low-concentration atropine eye drops during the study；
7. Those who have previously used orthokeratology lenses, peripheral defocusing glasses, multifocal soft lenses and other optical therapies to control the progression of myopia, and the elution period is less than three months；
8. Other situations in which the investigator believes that the patient is not suitable to participate in this study.

Where this trial is running

Guangzhou

• Sun Yat-sen University Zhongshan Ophthalmic Center (Zhujiang New Town Campus) — Guangzhou, China (Recruiting)

Study contacts

• Study coordinator: Chen Shuyu

Conditions Red Laser Light-Induced Retinopathy of Both Eyes